AWARE - Providin High Value
- 1. AWARE© Providing High Value Utilizing AWARE-Just Clinical© Clinical Market Program Guide December, 2016 Property of AWARE ©
- 2. Property of AWARE© MedClarity© - Clinical Market Program Guide is published by AWARE© , an industry consulting firm that specializes in business planning, marketing and sales program development, and training. This module is intended for informational purposes only and should not be relied upon as legal advice. All rights reserved. Copyright© 2016 This document may not be reproduced in whole or in part without the express written permission of the publisher. For more information contact Judy Elkourie: 205.913.4809 jaelkourie@gmail.com
- 3. Glossary Draw Center Location where the lab test is ordered and the specimen is collected. Direct Access Testing (DAT) Aka: Direct to Consumer (DTC) Consumers order lab tests directly from a lab without necessarily have to work with their healthcare provider. Aka: Patient-authorized testing Consumer initiated testing Some states do not allow DAT CLIA Clinical Laboratory Improvement Amendments Federal oversight to ensure accuracy and reliability of consumer test results Waived tests Subpart B, Certificate of Waiver, 42 CFR § 493.35-493.39. Property of AWARE©
- 4. Key Infrastructure Record-keeping and documentation Controlled confidentiality Consultation and treatment records maintained for each consumer Flagging system for special cases and scheduled evaluations Authorization for release of information documents Substance abuse testing records maintained in a confidential manner, isolated from the medical record Property of AWARE©
- 5. Policy and Procedures The manual includes statements on the following: Individual personnel responsibilities, including job descriptions Communications with employer management Liaison with health resources in the community Laboratory procedures Objectives and procedures for health programs Regulatory Requirements meetings: Examination of vehicle operators Hearing conservation Substance abuse testing Examinations relating to all legislated substances and hazards Property of AWARE©
- 6. Training Programs Establish a standard training format to provide the required health and safety training for the preparation of: Supervisors Employees Employees’ assigned responsibilities should be directly in compliance with the training that has been successfully completed. Examples of Training Topics Health Risk Management Preventive Health Services Health promotion, productivity, and well-being Monitoring chronic disease Property of AWARE©
- 7. Direct Access Testing Market On the Rise Source: Kalorama Information; 1/20/2016 Property of AWARE©
- 8. 20 Key Players in the Market 23andMe Any Lab Test Now Color Genomics Counsyl Direct Laboratory Services Gene by Gene HealthCheckUSA Home Access Health Laboratory Corp. MyMedLab Mapmygenome Pathway Genomics Positive Bioscience Quest Diagnostics Request a Test Sonora Quest Labs Theranos (Closed its lab operations Oct/2016 after federal regulators revoked the certificate for its California lab, saying it jeopardized patient safety. A series of investigative articles by the WSJ had called the accuracy of the company’s testing equipment into question) Walk-in Lab WellnessFX Xcode Life Sciences Source: MedCityNews.com, Jan/2016Property of AWARE©
- 9. What is Direct Access Testing (DAT)? Aka: Direct to consumer testing; patient-directed testing Characterized by: Individuals choosing which tests they would like from a limited menu Paying up-front for the cost Insurance does not typically cover this type of testing; insurance will not be billed Tests are ordered w/o any physician consultation Consumer is responsible for any follow-up with their clinician Some states do not allow for DAT Regulated at both federal and state levels Property of AWARE©
- 10. Why Use DAT? Lower out-of-pocket expense for consumers/patients who are uninsured or have a high deductible Some individuals may wish to have more frequent testing than their health care insurance plans will cover Monitor an existing health condition Identify a previously unknown medical disorder Provide data regarding personal health characteristics Great for people who wish to assess their health status on a regular basis Individuals who are away from their primary care provider or provider network can obtain needed laboratory testing Consumer self-empowerment in managing their health Consumer privacy concerns Convenience No appointment necessary Property of AWARE©
- 11. Disclaimer The laboratory results of direct access laboratory testing require additional expert interpretation and do not substitute for medical advice, diagnosis or treatment, which should be based on your physician's professional judgment, his or her review of your test results, the findings of physical examination and the review of your personal and family medical history. Property of AWARE©
- 12. Understanding Costs Key Principle The cost of an intervention should include not only the cost of the intervention itself but also any downstream costs, defined as costs that occur as a result of the intervention Costs that would not have occurred had the intervention not been done For example, the cost of an HIV screening program includes the cost not only of HIV testing but also of treating HIV in patients in whom HIV is diagnosed through the screening program Downstream savings should also be considered For example, consider patients with nonvalvular atrial fibrillation who are candidates for anticoagulation Although use of warfarin involves ongoing monitoring costs, the cost-savings from reduction in strokes more than outweigh the costs of the drug and monitoring Property of AWARE©
- 13. How Health Care Cost is Measured Preserve Quality Assessment of benefit and cost Effectiveness of the intervention Benefits, harms, evidence Downstream costs and savings CER (Comparative Effectiveness Research) “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care” that identifies “what works best for which patients under what circumstances” (Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. Accessed atwww.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx on 4 May 2010.) Property of AWARE©
- 14. Cost Effectiveness Ratio How to measure health benefit Conditions diagnosed or prevented or life-years or quality-adjusted life-years (QALYs) gained QALY is an important metric that is calculated by assessing how long a person lives and how persons assess quality of life during their lifetime Take into account the benefits from longer life or better quality of life The cost-effectiveness ratio is expressed in dollars per health outcome, such as dollars per life-year gained, per infection prevented, or per condition diagnosed Efficacy The impact of the intervention under ideal circumstances Effectiveness The impact of the intervention under typical, rather than ideal, circumstances Property of AWARE©
- 15. Summary of the different types of health economic analyses that have been employed with POCT, indicating the inputs to, and products of, the analyses Property of AWARE© Minimization
- 16. Types of Outcome Measures, 1 Clinical Mortality Death rate Morbidity Reduced rate of diabetic nephropathy Intermediate outcomes Reduction in HbA1c Time INR in therapeutic range Complication rate Recurrence rate Property of AWARE©
- 17. Types of Outcome Measures, 2 Operational Intermediate outcomes Emergency department triage time Length of stay in Emergency Department Number of clinic visits per year Operation time Recovery time Property of AWARE©
- 18. Types of Outcome Measures, 3 Economic Resource utilization Cost per QALY Intermediate outcomes Emergency admission rate Length of stay in Emergency Department Blood product utilization Clinic costs Cost per episode Property of AWARE©
- 19. Why Do We Need POCT? Evidence-based medical decisions in “real time” Eliminates need for ordering additional, unnecessary tests Reduction in unneeded medications “Perceived” patient benefits Reduction in duplicate test orders Reduced consumption of other expensive services/products (lab tests, pharmaceuticals) Property of AWARE©
- 20. Test Life Cycle Centralized Lab Test ordered Test request processed Specimen obtained Specimen transported to lab Specimen processed by lab Specimen analyzed Results reviewed by lab staff Results reported to clinician Clinician acts on results Point of Care Test ordered Specimen obtained Specimen analyzed Clinician acts on result Property of AWARE©
- 21. POCT Value POCT can provide more rapid test results, allow faster clinical decision-making, and decrease the cost of care. 70% of all physician decisions today are informed by clinical lab results According to the American Diabetes Association, healthcare costs for the Medicare-eligible population is expected to rise from $45 billion to $171 billion by 2034 The Congressional Diabetes Caucus reports Medicare beneficiaries with diabetes account for 32 percent of Medicare spending — nearly one-third of the program’s expenditures. Regular lab testing for diabetes can prevent ore costly complications down the road, such as hospitalization, heart attack, high blood pressure, kidney failure/dialysis *thehill.com/.../198640-alan-mertz-lab-testing-a-medicare-cost-savings/Feb 18, 2014 Property of AWARE©
- 22. Added AWARE Just Clinical Value Providing clinical information that enables the healthcare provider to take advantage of a teachable moment A flu or Strep test can help patients understand when they do (and don’t) need a prescription for an antiviral or antibiotic An HIV test given to a high-risk individual who is unaware of their infection can lead to rapid counseling and initiation of therapy Providing clinical information in acute care settings faster than it could be delivered by a conventional laboratory Property of AWARE©
- 23. For Example: Group A Streptococcal Pharyngitis Early recognition and treatment important Shorten duration of clinical illness Prevent transmission Prevent sequelae Rheumatic heart disease Glomerulonephritis Property of AWARE©
- 24. What About an Abnormal Result? What is the predictive value of the test for the disease in question? Is the result meaningful? What other factors could produce the result (interfering substances/diet considerations)? Peroxidase activity and false-positive results FOBT and diet high in red meat consumption FOBT an uncooked turnips, broccoli, bananas, black grapes, pears, plums, melons WBCs and bacteria What should be done next? If the diagnosis has already been made, the test results can be used in managing the patient’s treatment plan Are changes in therapy indicated? When should the next test be performed? Property of AWARE©
- 25. Ultimate Economic Considerations Look beyond “cost per test” Judge cost-effectiveness in the context of “total cost of patient care” Property of AWARE©
- 26. The Medically Necessary Standard for Insurance Coverage By statute, the U.S. Medicare program provides coverage for products that are “reasonable and necessary” for the diagnosis and treatment of Medicare beneficiaries. Since the Affordable Care Act, CMS now covers any preventive services it determines are “reasonable and necessary for the prevention or early detection of an illness or disability” and that have been endorsed by the U.S. Preventive Services Task Force Property of AWARE©
- 27. Educational Needs Assessment Identify the state of knowledge and interest of a defined audience in order to design effective clinical educational programs Goals: What does the audience already know/think to determine what educational programs are needed Making the educational programs more accessible, acceptable, and useful to our clientele Objectives tend to focus on what is needed to change knowledge, behavior, and/or conditions Diagnosis Medications Emergency situations Property of AWARE©
- 28. Example of Learning Needs Assessment Tool 1. Can you tell me what you are being treated for? 2. In general, how much do you feel you know about it? (A lot, In between, Not very much) 3. Are you taking any medications for your conditions? 4. What medications are you taking? 5. How often do you take each one? 6. What special treatments or procedures, such as exercise or diet, have you been told to carry out by your doctor? 7. What signs or symptoms would cause you to seek immediate help for your condition? 8. Of the following kinds of information which 2 do you think are most important? 1. When to seek help? 2. What things am I allowed to do? 3. Will I get better? 4. What is my treatment? 9. How correctable is your condition? (Totally correctable, Partially correctable, Not correctable) 10. Do you feel you have been given enough information to effectively partner in your health care? Property of AWARE©
- 29. Questions? Judy A Elkourie, BSN, RN, CPHM AWARE – Just Clinical© 205.913.4809 jaelkourie@gmail.com Property of AWARE©